BEUDAMED
    FDA Enforcement Class I Ongoing

    DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF

    Recall: Z-0446-2026 · Reported November 19, 2025

    Enforcement

    Recall Number
    Z-0446-2026
    Event ID
    97882
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 19, 2025
    Initiation Date
    October 10, 2025
    Classification Date
    November 13, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF

    Reason

    Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

    Code Info

    CYSTO DYNJ909127F UDI-DI 40198459055424 (case), 10198459055423 (ea) Lots 25FBP819 25GBM605; GENERAL LAPAROSCOPY-LF DYNJ909129D UDI-DI 40198459055264 (case), 10198459055263 (ea) Lots 25FBV537; ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909119G UDI-DI 40198459130527 (case), 10198459130526 (ea) Lots 25FBP681

    Distribution

    International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;

    Quantity

    96,406 total units